Heart Failure, CongestiveNCT00112125
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
A study testing OPTIMIZER System in people with Heart Failure, Congestive, run by Impulse Dynamics at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- OPTIMIZER System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to 19 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are 18 years of age or older
- Subjects who are either male or female
- Subjects who have a baseline ejection fraction of 35% or less by echocardiography.
- Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the patient is intolerant) and are in New York Heart Association functional Class III or IV at the time of enrollment.
- Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
- Subjects who, in the opinion of the Principle Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD) and/or pacemaker, must have an existing device or agree to undergo implantation of such a device unless the patient refuses to undergo the implantation of such device for personal reasons.
- Subjects who are willing and able to return for all follow-up visits.
Who cannot join
- Subjects whose baseline VO2,max is <9 ml 02/min/kg.
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or electrocardiography (ECG) changes during exercise testing performed during baseline evaluation.
- Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
- Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular complexes (PVCs) per 24 hours on baseline Holter monitoring.
- Subjects who have chronic atrial fibrillation or chronic atrial flutter or those cardioverted within 30 days of enrollment.
Show all 14Show fewer
- Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, chronic obstructive pulmonary disease [COPD], peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk or a cardiopulmonary stress test.
- Subjects who are scheduled for a coronary artery bypass graft (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
- Subjects who have a biventricular pacing system or who have an accepted indication for such a device.
- Subjects who have had a myocardial infarction within 90 days of enrollment.
- Subjects who have mechanical tricuspid or aortic valves.
- Subjects who have a prior heart transplant.
- Subjects who are participating in another experimental protocol.
- Subjects who are unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of the OPTIMIZER System With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
Read the detailed description
IMPULSE Dynamics' FIX HF 5 US Study is a prospective, multi-center, study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER™ System in patients with NYHA class III/IV heart failure. The study will involve the recruitment of approximately 420 subjects at a total of up to 50 sites nationwide.
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER™ System or to a control group. All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive optimal medical therapy for the treatment of their heart failure.
The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months. Safety variables, such as the rate and cause of hospitalizations or death, shall be collected in both groups and shall be compared at 12 months.
- Conditions
- Heart Failure, Congestive
- Being tested
- OPTIMIZER System
- Keywords
- cardiac contractility modulation, heart failure, cardiopulmonary exercise test, chronic heart disease
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMIZER SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Optimizer System + Optimal medical treatment | Experimental | Optimizer System implanted and cardiac contractility modulation therapy activated. Receives: Device: OPTIMIZER System |
| Optimal medical treatment | No intervention | Treatment with optimal medical therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint: Ventilatory Anerobic Threshold (VAT)
Number of participants with improvement in exercise tolerance at 24 weeks compared to baseline, as quantified by VO2 at ventilatory anerobic threshold (VAT) measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab.
Note: An individual subject is considered a responder if VAT increases by ≥20% at 24 weeks compared to their respective baseline value.
Measured: 24 weeks
Safety Endpoint: Composite All-cause Mortality and All-cause Hospitalizations
The proportion of patients experiencing a composite event of all-cause mortality and all-cause hospitalizations evaluated at 50-weeks
Measured: 50-weeks
Secondary outcomes (4)
Peak VO2
Number of participants with improvement in peak VO2 measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab.
Note: An individual subject is considered a responder if peak VO2 increases by ≥20% at 24 weeks compared to their respective baseline value.
Measured: 24 weeks
New York Heart Association (NYHA) Functional Classification
Number of participants with improvement in heart failure symptoms as quantified by a blinded clinician using the New York Heart Association (NYHA) functional classification at 24 weeks compared to baseline. The NYHA Class ranges from I - IV, with a lower class indicating a better status.
Note: An individual subject is considered a responder if the NYHA class decreases by ≥ 1 at 24 weeks compared to their respective baseline class.
Measured: 24 weeks
Minnesota Living With Heart Failure (MLWHF) Questionnaire
Number of subjects will improvement in quality of life at 24 weeks compared to baseline, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The MLWHFQ score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
Note: An individual subject is considered a responder if the MLWHFQ score decreases by ≥10 points at 24 weeks compared to their respective baseline score.
Measured: 24 weeks
Six Minute Hall Walk (6MW) Test
Number of subjects with improvement in exercise tolerance at 24 weeks compared to baseline, as assessed by the the six minute hall walk (6MW) test.
Note: An individual subject is considered a responder with >40-meter increase in distance walked at 24 weeks compared to their respective baseline distance.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startFeb 2005
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Burkhoff, M.D, Ph.D., Study director, Impulse Dynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112125
- Sponsor's protocol ID
- #IDPT 2003-07-C
- Other IDs
- FIX-HF-5
- Status last verified
- Jul 2020
- First submitted
- 27 May 2005
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Burkhoff D, Shemer I, Felzen B, Shimizu J, Mika Y, Dickstein M, Prutchi D, Darvish N, Ben-Haim SA. Electric currents applied during the refractory period can modulate cardiac contractility in vitro and in vivo. Heart Fail Rev. 2001 Jan;6(1):27-34. doi: 10.1023/a:1009851107189. No abstract available.
PubMed 11248765Ellison K. Nonexcitatory stimulation: 2002: a pace odyssey. J Cardiovasc Electrophysiol. 2002 Jul;13(7):696-7. doi: 10.1046/j.1540-8167.2002.00696.x. No abstract available.
PubMed 12139295Marrouche NF, Pavia SV, Zhuang S, Kim YJ, Tabata T, Wallick D, Saad E, Abdul-Karim A, Schweikert R, Saliba W, Tchou P, Natale A. Nonexcitatory stimulus delivery improves left ventricular function in hearts with left bundle branch block. J Cardiovasc Electrophysiol. 2002 Jul;13(7):691-5. doi: 10.1046/j.1540-8167.2002.00691.x.
PubMed 12139294Mohri S, He KL, Dickstein M, Mika Y, Shimizu J, Shemer I, Yi GH, Wang J, Ben-Haim S, Burkhoff D. Cardiac contractility modulation by electric currents applied during the refractory period. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1642-7. doi: 10.1152/ajpheart.00959.2001.
PubMed 11959626Morita H, Suzuki G, Haddad W, Mika Y, Tanhehco EJ, Sharov VG, Goldstein S, Ben-Haim S, Sabbah HN. Cardiac contractility modulation with nonexcitatory electric signals improves left ventricular function in dogs with chronic heart failure. J Card Fail. 2003 Feb;9(1):69-75. doi: 10.1054/jcaf.2003.8.
PubMed 12612875Mohri S, Shimizu J, Mika Y, Shemer I, Wang J, Ben-Haim S, Burkhoff D. Electric currents applied during refractory period enhance contractility and systolic calcium in the ferret heart. Am J Physiol Heart Circ Physiol. 2003 Apr;284(4):H1119-23. doi: 10.1152/ajpheart.00378.2002. Epub 2002 Nov 21.
PubMed 12446280Sabbah HN, Haddad W, Mika Y, Nass O, Aviv R, Sharov VG, Maltsev V, Felzen B, Undrovinas AI, Goldstein S, Darvish N, Ben-Haim SA. Cardiac contractility modulation with the impulse dynamics signal: studies in dogs with chronic heart failure. Heart Fail Rev. 2001 Jan;6(1):45-53. doi: 10.1023/a:1009855208097.
PubMed 11248767Pappone C, Rosanio S, Burkhoff D, Mika Y, Vicedomini G, Augello G, Shemer I, Prutchi D, Haddad W, Aviv R, Snir Y, Kronzon I, Alfieri O, Ben-Haim SA. Cardiac contractility modulation by electric currents applied during the refractory period in patients with heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 2002 Dec 15;90(12):1307-13. doi: 10.1016/s0002-9149(02)02868-0.
PubMed 12480039Abraham WT, Burkhoff D, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, Kadish A; FIX-HF-5 Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.
PubMed 18926146
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the OPTIMIZER System With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5
- ClinicalTrials.gov ID
- NCT00112125
- Acronym / sponsor ID
- #IDPT 2003-07-C
- Conditions
- Heart Failure, Congestive
- Keywords
- cardiac contractility modulation, heart failure, cardiopulmonary exercise test, chronic heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2005 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 30 May 2005 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
Detailed description
IMPULSE Dynamics' FIX HF 5 US Study is a prospective, multi-center, study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER™ System in patients with NYHA class III/IV heart failure. The study will involve the recruitment of approximately 420 subjects at a total of up to 50 sites nationwide.
Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER™ System or to a control group. All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive optimal medical therapy for the treatment of their heart failure.
The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months. Safety variables, such as the rate and cause of hospitalizations or death, shall be collected in both groups and shall be compared at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimizer System + Optimal medical treatment | Experimental | Device: OPTIMIZER SystemOptimizer System implanted and cardiac contractility modulation therapy activated. |
| Optimal medical treatment | No intervention | –Treatment with optimal medical therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are 18 years of age or older
- Subjects who are either male or female
- Subjects who have a baseline ejection fraction of 35% or less by echocardiography.
- Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the patient is intolerant) and are in New York Heart Association functional Class III or IV at the time of enrollment.
- Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
Key exclusion criteria (14 listed)
- Subjects whose baseline VO2,max is <9 ml 02/min/kg.
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or electrocardiography (ECG) changes during exercise testing performed during baseline evaluation.
- Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
- Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular complexes (PVCs) per 24 hours on baseline Holter monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMIZER System | Device | Optimizer System + Optimal medical treatment |
Primary outcome
Efficacy Endpoint: Ventilatory Anerobic Threshold (VAT)
Time frame: 24 weeks
Number of participants with improvement in exercise tolerance at 24 weeks compared to baseline, as quantified by VO2 at ventilatory anerobic threshold (VAT) measured on cardiopulmonary exercise stress testing (CPX), and evaluated by a blinded core lab. Note: An individual subject is considered a responder if VAT increases by ≥20% at 24 weeks compared to their respective baseline value.
Safety Endpoint: Composite All-cause Mortality and All-cause Hospitalizations
Time frame: 50-weeks
The proportion of patients experiencing a composite event of all-cause mortality and all-cause hospitalizations evaluated at 50-weeks
4 secondary outcomes
Peak VO2
Time frame: 24 weeks
New York Heart Association (NYHA) Functional Classification
Time frame: 24 weeks
Minnesota Living With Heart Failure (MLWHF) Questionnaire
Time frame: 24 weeks
Six Minute Hall Walk (6MW) Test
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11248765Burkhoff D, Shemer I, Felzen B, Shimizu J, Mika Y, Dickstein M, Prutchi D, Darvish N, Ben-Haim SA. Electric currents applied during the refractory period can modulate cardiac contractility in vitro and in vivo. Heart Fail Rev. 2001 Jan;6(1):27-34. doi: 10.1023/a:1009851107189. No abstract available.
- Background: PubMed 12139295Ellison K. Nonexcitatory stimulation: 2002: a pace odyssey. J Cardiovasc Electrophysiol. 2002 Jul;13(7):696-7. doi: 10.1046/j.1540-8167.2002.00696.x. No abstract available.
- Background: PubMed 12139294Marrouche NF, Pavia SV, Zhuang S, Kim YJ, Tabata T, Wallick D, Saad E, Abdul-Karim A, Schweikert R, Saliba W, Tchou P, Natale A. Nonexcitatory stimulus delivery improves left ventricular function in hearts with left bundle branch block. J Cardiovasc Electrophysiol. 2002 Jul;13(7):691-5. doi: 10.1046/j.1540-8167.2002.00691.x.
- Background: PubMed 11959626Mohri S, He KL, Dickstein M, Mika Y, Shimizu J, Shemer I, Yi GH, Wang J, Ben-Haim S, Burkhoff D. Cardiac contractility modulation by electric currents applied during the refractory period. Am J Physiol Heart Circ Physiol. 2002 May;282(5):H1642-7. doi: 10.1152/ajpheart.00959.2001.
- Background: PubMed 12612875Morita H, Suzuki G, Haddad W, Mika Y, Tanhehco EJ, Sharov VG, Goldstein S, Ben-Haim S, Sabbah HN. Cardiac contractility modulation with nonexcitatory electric signals improves left ventricular function in dogs with chronic heart failure. J Card Fail. 2003 Feb;9(1):69-75. doi: 10.1054/jcaf.2003.8.
- Background: PubMed 12446280Mohri S, Shimizu J, Mika Y, Shemer I, Wang J, Ben-Haim S, Burkhoff D. Electric currents applied during refractory period enhance contractility and systolic calcium in the ferret heart. Am J Physiol Heart Circ Physiol. 2003 Apr;284(4):H1119-23. doi: 10.1152/ajpheart.00378.2002. Epub 2002 Nov 21.
- Background: PubMed 11248767Sabbah HN, Haddad W, Mika Y, Nass O, Aviv R, Sharov VG, Maltsev V, Felzen B, Undrovinas AI, Goldstein S, Darvish N, Ben-Haim SA. Cardiac contractility modulation with the impulse dynamics signal: studies in dogs with chronic heart failure. Heart Fail Rev. 2001 Jan;6(1):45-53. doi: 10.1023/a:1009855208097.
- Background: PubMed 12480039Pappone C, Rosanio S, Burkhoff D, Mika Y, Vicedomini G, Augello G, Shemer I, Prutchi D, Haddad W, Aviv R, Snir Y, Kronzon I, Alfieri O, Ben-Haim SA. Cardiac contractility modulation by electric currents applied during the refractory period in patients with heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 2002 Dec 15;90(12):1307-13. doi: 10.1016/s0002-9149(02)02868-0.
- Derived from this study: PubMed 18926146Abraham WT, Burkhoff D, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, Kadish A; FIX-HF-5 Investigators and Coordinators. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Burkhoff, M.D, Ph.D. study director
Impulse Dynamics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMIZER System in people with Heart Failure, Congestive, run by Impulse Dynamics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoint: Ventilatory Anerobic Threshold (VAT) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112125, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.